Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Novartis

Status and phase: Completed; Phase 2

Conditions: Advanced Triple Negative Breast Cancer (TNBC) With High TAMs

Treatments: Drug: gemcitabine; Drug: MCS110; Drug: carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02435680

2015-000179-29 (EudraCT Number)

CMCS110Z2201

Details and patient eligibility

About

To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult women (≥ 18 years of age) with advanced TNBC.
• Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.
• ER/PgR negativity to follow local guidelines
• If IHC HER2 2+, a negative FISH test is required
• A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory
• Patients must have:

At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)

Exclusion criteria

• Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
• Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
• Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
• Radiotherapy
• Major surgery
• Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
• Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
• Patients with the following laboratory values during screening and on Day 1 predose:
• Absolute Neutrophil Count (ANC) < 1.5x109/L
• Hemoglobin < 9 g/dL
• Platelets < 100x109/L
• Serum creatinine > 1.5 x ULN
• Serum total bilirubin > 1.5 x ULN
• AST/SGOT and ALT/SGPT > 3.0 x ULN

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm 1: MCS110+carboplatin+gemcitabine

Experimental group

Description:

MCS110+carboplatin+gemcitabine

Treatment:

Drug: gemcitabine

Drug: carboplatin

Drug: MCS110

Arm 2: carboplatin+gemcitabine

Active Comparator group

Description:

carboplatin+gemcitabine

Treatment:

Drug: gemcitabine

Drug: carboplatin